Cleared Traditional

K250446 - Frida Anterior Cervical Plate System

K250446 is an FDA 510(k) clearance for Frida Anterior Cervical Plate System, manufactured by Spineup, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K250446 · Spineup, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
98d
Days
Class 2
Risk

K250446 is an FDA 510(k) clearance for the Frida™ Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spineup, Inc. (Hollywood, US). The FDA issued a Cleared decision on May 23, 2025 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spineup, Inc. devices

FDA 510(k) Submission Details - K250446

510(k) Number K250446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date May 23, 2025
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 482
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K250446.
aprevo® cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System
K251965 · Alphatec Spine, Inc. · Aug 2025
Resolve Anterior Cervical Plate System
K251436 · Pioneer Surgical Technology, Inc. · Jul 2025
X-PAC® N-GAGE™ Lumbar Plate System
K250602 · Expanding Innovations, Inc. · May 2025
Skyway Anterior Cervical Plate System
K250486 · Kyocera Medical Technologies Inc. (KMTI) · Apr 2025
Elegance® Anterior Cervical plate
K243904 · Clariance · Jan 2025